Telerehabilitation and Tele-psychological Support in Cancer Patients eCAN JA
NCT ID: NCT06007001
Last Updated: 2024-04-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
354 participants
INTERVENTIONAL
2023-09-25
2024-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The eCAN JA explores the role of telemedicine tools (i.e. TC \& TM) in clinical trials focusing on tele-rehabilitation and tele-psychological support in different populations of cancer patients in 10 European countries. The pilots will be conducted among 354 patients affected by breast (BC, pilot 1a), head \& neck (H\&N, pilot 1b) and advanced (pilot 2) cancers.
The main aim is to assess the effect of TC and TM program focused on rehabilitation and psychological support for cancer patients on patient reported outcomes measures (PROMs) in three pilots compare to usual care.
Patients will be randomly assigned either to the intervention or control groups using a 1:1 ratio. Patients in the intervention group will receive weekly TC of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters. Patients in the control group will receive usual care.
PROMs (i.e. quality of life, distress and pain) and physical parameters (i.e. physical activity, sleep quality and heart rate) will be monitored by a dedicated telemonitoring systems. A secure web platform will provide dashboard to clinicians for decision support. Patients' experience and costs data will be also collected. The results of the eCAN project will improve our knowledge on benefits and risks for TC and TM in cancer patients care.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
e-Motion : Promoting Emotion Regulation in Chronic Cancer
NCT07236021
Digitizing Cancer Rehabilitation During and After Systemic Treatment: Feasibility Testing Implementation in South Baltic Countries
NCT06768918
Cancer and Disorders of Cognitive Functions and Quality of Life: "Cognitive Rehabilitation in Patients Suffering From Cancer and Treated With Chemotherapy"
NCT01788618
e-CUIDACHEMO: Telerehabilitation During Chemotherapy in Breast Cancer
NCT02350582
Cancer Prevention Among Individuals with Mental Ill-health: Patient Navigation for Primary Cancer Prevention
NCT06435117
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Telemedicine
Patients in the intervention group will receive weekly teleconsultation of 30 minutes during 8 weeks through the secure Edumeet platform. In pilot 1, tele-rehabilitation training will be performed by a remote physiotherapist and will consist of a series of rehabilitation exercises. In pilot 2, tele-psychological support will be performed by a remote psychologist and will consist of techniques for managing emotions and stress. In the intervention group, patients will also have the possibility to wear a smartwatch to automatically collect physical parameters.
Telemedicine
Pilot 1a/b : the tele-rehabilitation intervention in BC or H\&N operated patients will consist of a series of exercises. The physiotherapist during teleconsultation rehabilitation program will explain to the patient how to perform the movements and regulate breathing. Practical advice on correct and incorrect habits will also be dispensed by the physiotherapist during the teleconsultation.
Pilot 2: the tele-rehabilitation intervention will consist of tele psychological support performed by a trained psychologist in each participating center It will consist of the learning of techniques for managing negative emotions, for relaxation and for implementing effective behavioural and coping strategies.
For each group, the TC will be scheduled every week for 8 weeks. The session will be available on a secure platform (Edumeet). Moreover, if they agree to, patients will also wear a smart watch to monitor physical parameters such as physical activity, sleeping and heart rate.
Usual care
Patients in the control group will receive usual care.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Telemedicine
Pilot 1a/b : the tele-rehabilitation intervention in BC or H\&N operated patients will consist of a series of exercises. The physiotherapist during teleconsultation rehabilitation program will explain to the patient how to perform the movements and regulate breathing. Practical advice on correct and incorrect habits will also be dispensed by the physiotherapist during the teleconsultation.
Pilot 2: the tele-rehabilitation intervention will consist of tele psychological support performed by a trained psychologist in each participating center It will consist of the learning of techniques for managing negative emotions, for relaxation and for implementing effective behavioural and coping strategies.
For each group, the TC will be scheduled every week for 8 weeks. The session will be available on a secure platform (Edumeet). Moreover, if they agree to, patients will also wear a smart watch to monitor physical parameters such as physical activity, sleeping and heart rate.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Pilot 1b: All consenting adult patients, aged between 18 and 75 years old, with histopathologically proven H\&N cancer who are prescheduled for an en bloc resection of the primary tumor, neck dissection, or reconstruction in a cancer center of participating European countries will be eligible for this study.
* Pilot 2: All consenting adult patients, aged between 18 and 75 years old, affected by advanced/recurrent cancer (including lung, prostate, colorectum, breast cancer, gastric, genito-urinary) will be eligible for this study.
Exclusion Criteria
* For pilot 2: Patients are ineligible to participate if they meet one of the following criteria: (I) unable to sign informed consent; (II) present relevant cognitive deterioration; (III) performance status \> ECOG 2; (IV) previous diagnosis of major depression, the presence of mood disorders will be assessed with Personal Health Questionnaire Depression Scale (PHQ-8) (13); (V) starting antidepressant pharmacological treatment in the last 4 weeks before the enrollment; (VI) taking antipsychotic treatment, (VII) not having access to an internet connection (VIII) not having access to an android smartphone or (IX) already involved in other telemedicine services.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
European Commission
OTHER
Sciensano
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Andrea Pace, Dr
Role: PRINCIPAL_INVESTIGATOR
Neuro-Oncology Unit, Regina Elena Cancer Institute, Italy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Antwerp University Hospital (UZA)
Antwerp, , Belgium
German Oncology Center (GOC)
Ágios Athanásios, , Cyprus
CUT
Limassol, , Cyprus
The Bank of Cyprus Oncology Center (BOCOC)
Stróvolos, , Cyprus
Aristotle University of Thessaloniki
Thessaloniki, , Greece
National Institute of Oncology
Budapest, , Hungary
Dr Steevens Hospital
Dublin, , Ireland
The National Cancer Institute of Naples (INT Pascale)
Naples, , Italy
The Regina Elena National Cancer Institute (IFO-IRE)
Roma, , Italy
Hospital of Lithuanian University of Health Sciences Kauna Klinikos (KK)
Kaunas, , Lithuania
National Cancer Institute (NCI)
Vilnius, , Lithuania
Vilnius University Hospital Santaros Klinikos VULSK
Vilnius, , Lithuania
Portuguese Institute of Cancer of Coimbra (IPO)
Coimbra, , Portugal
Portuguese Institute of Cancer of Lisbon (IPO)
Lisbon, , Portugal
Portuguese Institute of Cancer of Porto (IPO)
Porto, , Portugal
The institute of Oncology Ljubljana (OIL)
Ljubljana, , Slovenia
IDIVAL
Santander, , Spain
Andalusian Health Service
Seville, , Spain
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Eleni Timotheadou
Role: primary
József Lövey, Dr
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
eCAN pilots
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.